QC Sr Analyst Flow Cytometry and Molecular

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) program

Educational assistance

Job summary

RoslinCT is seeking a Quality Control Senior Analyst with a specialty in Flow Cytometry and Molecular assays in Hopkinton, MA. The role focuses on analytical method transfer, optimization, troubleshooting, and data reporting within a cGMP QC environment.

Ideal candidates have 6+ years in QC manufacturing, experience with cell-based assays, and strong documentation, communication, and teamwork skills. Weekend/holiday coverage and potential shift flexibility are required.

Qualifications

• Bachelor's degree in a scientific discipline.
• 6+ years' experience in Quality Control manufacturing environment.
• Familiarity/experience in a cGMP QC laboratory is desirable
• Ability to adhere to timelines for testing and reporting of data
• Ability to function in a team-oriented environment
• Excellent/Effective written and verbal communications skills
• Adhere to scheduled timelines while maintaining flexibility and attention to detail
• Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities
• Weekend and Holidays, are required. Flexible shift work may be required on occasion in support of 24/7 manufacturing operations.
• Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.

Responsibilities

• Conduct routine and non-routine analyses of samples for in-process, final product, and stability samples.
• Execute sampling and QC sample management activities per procedure or written protocols.
• Knowledge of analytical method lifecycle guidance (e.g., ICH).
• Experience in cell-based assays, Flow Cytometry, ELISA, qPCR, dPCR.
• Execute and support GMP cell culture and cell based assays for In-process, release, stability and method qualification activities.
• Perform aseptic cell culture techniques, including cell thawing, expansion, Maintenance, counting, viability assessment, harvesting and preparation of cells for downstream testing.
• Maintain cell lines ensuring appropriate documentation, traceability, storage and inventory controls, as needed.
• Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
• Write/revise QC specific procedures and protocols.
• Troubleshoot technical issues with Assays.
• Train and mentor QC analyst on all the approved methods, GMP documentation and laboratory best practices.
• Support implementation of information technologies that support documentation and data management systems.
• Own investigations, change controls and CAPAs.
• Other duties as assigned.

Skills

Organized work style

Attention to accuracy

MS Office proficiency

Problem solving

Communication skills

Education

Bachelor's degree in scientific discipline

Job description

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Quality Control Sr. Analyst with a specialty in Flow Cytometry and Molecular assays will be executing analytical method transfer to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring protocols, authoring Standard Operating Procedures (SOP’s) and Test Methods. He/she will be executing various quality control methods, analyzing and reporting data. He/she will assist in the implementation of new assay methodologies and the associated instrumentation and may support equipment onboarding activities. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratories investigation in compliance with all applicable quality systems and current cGMP’s. This position is highly visible in the organization and requires the ability to interface with multiple groups.

How You Will Make an Impact:

• Conduct routine and non-routine analyses of samples for in-process, final product, and stability samples.
• Execute sampling and QC sample management activities per procedure or written protocols.
• Knowledge of analytical method lifecycle guidance (e.g., ICH)
• Experience in cell-based assays, Flow Cytometry, ELISA, qPCR, dPCR
• Execute and support GMP cell culture and cell based assays for In-process, release, stability and method qualification activities.
• Perform aseptic cell culture techniques, including cell thawing, expansion, Maintenance, counting, viability assessment, harvesting and preparation of cells for downstream testing.
• Maintain cell lines ensuring appropriate documentation, traceability, storage and inventory controls, as needed.
• Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
• Write/revise QC specific procedures and protocols.
• Troubleshoot technical issues with Assays.
• Train and mentor QC analyst on all the approved methods, GMP documentation and laboratory best practices.
• Support implementation of information technologies that support documentation and data management systems.
• Own investigations, change controls and CAPAs.
• Other duties as assigned.

What You Will Bring:

• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Qualifications:

• Bachelor's degree in scientific discipline.
• 6+ years' experience in Quality Control manufacturing environment
• Familiarity/experience in a cGMP QC laboratory is desirable
• Ability to adhere to timelines for testing and reporting of data
• Ability to function in a team-oriented environment
• Excellent/Effective written and verbal communications skills
• Adhere to scheduled timelines while maintaining flexibility and attention to detail
• Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities
• Weekend and Holidays, are required. Flexible shift work may be required on occasion in support of 24/7 manufacturing operations.
• Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.